Fluorouracil

Product NDC: 0378-4791
11-digit product format: 003784791
Labeler code: 0378
Product ID: 0378-4791_1ff72539-1af5-41bf-8720-1ba12df35abc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorouracil
Dosage form: CREAM
Route: TOPICAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA016831
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-09-19
Substance: FLUOROURACIL
Active strength: 5 mg/g
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016831-001	EFUDEX	FLUOROURACIL	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982
N016831-002	EFUDEX	FLUOROURACIL	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982
N016831-003	EFUDEX	FLUOROURACIL	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N016831-001	AT
N016831-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016831-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016831-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016831-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016831-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016831-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016831-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016831-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016831-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016831-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016831-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016831-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016831-002	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016831-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016831-001	AT	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluorouracil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOROURACIL	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3P01618RT	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
744737c5-0d96-4214-82ab-6cff016b1ea0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dc9482d-9b87-4471-9708-4f1b4585846b	Product name	2	20250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb	Product name	5	20250630
dc0d2364-4811-4665-a3ee-7ed8c7301465	Product name	2	20171219
62fb8671-1693-49d8-8aab-0c1bfdd6794e	Product name	1	20151005
878ca466-81fd-9d24-1349-31baf36065c6	Product name	2	20150506
630d1bc2-ae6b-fd31-1264-c4733e788193	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-4791-06	Fluorouracil	1 in 1 CARTON	CREAM	1		11
0378-4791-06	Fluorouracil	40 g in 1 TUBE	CREAM	40		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4791-06	GM - Gram	0378-4791	d4020f81-d7e1-4a5e-ada1-863ebd27a858	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluorouracil	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
Fluorouracil	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4791	FLUOROURACIL CREAM [MYLAN PHARMACEUTICALS INC.]	11	Current NDC, Legacy NDC, 2 package rows	20230708_744737c5-0d96-4214-82ab-6cff016b1ea0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Efudex	FLUOROURACIL	Bausch Health US, LLC	35de1c1c-bef5-46c5-b6f8-ea032147411c	2025-04-23		Exact identifier application applno (NDA): 016831 application number: NDA016831
Fluorouracil	FLUOROURACIL	Mylan Pharmaceuticals Inc.	744737c5-0d96-4214-82ab-6cff016b1ea0	2021-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016831 application number: NDA016831 ndc (product): 0378-4791

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4791-06	00378479106	1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE	1 tube	2013-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluorouracil - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2021-06-30	HUMAN PRESCRIPTION DRUG LABEL	11